SYNTHROID®levothyroxine sodium tablets, USP

This initial dose is followed by daily supplements of 100 to 200 mcg given IV. Normal T4 levels are achieved in 24 hours followed in 3 days by threefold elevation of T3. Oral therapy with thyroid hormone would be resumed as soon as the clinical situation has synthroid insert been stabilized and the patient is able to take oral medication. In adult patients with primary (thyroidal) hypothyroidism, serum TSH levels (using a sensitive assay) alone may be used to monitor therapy.

Certain other medicines may also increase or decrease the effects of Synthroid. Since thyroid hormone occurs naturally in the body, almost anyone can take levothyroxine. However, you may not be able to take this medicine if you have certain medical conditions. Consumption of certain foods may affect levothyroxine absorption thereby necessitating adjustments in dosing.

3 Recommended Dosage and Titration

Seizures occurred in a 3-yearold child ingesting 3.6 mg of levothyroxine. Titrate the dose of SYNTHROID carefully and monitor response to titration to avoid these effects see DOSAGE AND ADMINISTRATION. Consider the potential for food or drug interactions and adjust the administration or dosage of SYNTHROID as needed see DOSAGE AND ADMINISTRATION, DRUG INTERACTIONS and CLINICAL PHARMACOLOGY. Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your thyroid hormone levels and also make levothyroxine less effective. Many other medicines can be affected by your thyroid hormone levels.

The appearance of angina is an indication for a reduction in dosage. Undertreatment and overtreatment should be avoided (see PRECAUTIONS – Pediatric Use). SYNTHROID may be administered to infants and children who cannot swallow intact tablets by crushing the tablet and suspending the freshly crushed tablet in a small amount (5-10 mL or 1-2 teaspoons) of water. Foods that decrease absorption of levothyroxine, such as soybean infant formula, should not be used for administering levothyroxine sodium tablets (see PRECAUTIONS – Drug-Food Interactions). The initial dose of levothyroxine varies with age and body weight (see DOSAGE AND ADMINISTRATION – Table 3).

Pediatric Dosage – Congenital or Acquired Hypothyroidism

The protein anabolic effects of thyroid hormones are essential to normal growth and development. Addition of levothyroxine therapy in patients with diabetes mellitus may worsen glycemic control and result in increased antidiabetic agent or insulin requirements. Carefully monitor glycemic control after starting, changing, or discontinuing SYNTHROID see Drug Interactions (7.2).

Decreased Bone Mineral Density Associated With Thyroid Hormone Over-Replacement

Use the serum free-T4 level to titrate SYNTHROID dosing until the patient is clinically euthyroid and the serum free-T4 level is restored to the upper half of the normal range see Recommended Dosage And Titration. Thyroid hormones, including SYNTHROID, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss. In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. Larger doses may produce serious or even life-threatening manifestationsof toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects. Use the serum free-T4 level to titrate SYNTHROID dosing until the patient is clinically euthyroid and the serum free-T4 level is restored to the upper half of the normal range. Myxedema coma is a life-threatening emergency characterized by poor circulation and hypometabolism, and may result in unpredictable absorption of levothyroxine sodium from the gastrointestinal tract.

Levothyroxine is also used in adults along with surgery and radioactive iodine therapy to treat a certain type of thyroid cancer. NP Thyroid is used for hashimoto’s disease, hypothyroidism, after thyroid removal, thyroid cancer … It may take several weeks before your body starts to respond to Synthroid.

• You are encouraged to report negative side effects of prescription drugs to the FDA.
• Because of the increased prevalence of cardiovascular disease among the elderly, initiate SYNTHROID at less than the full replacement dose see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS.
• Having hypothyroidism during pregnancy may increase the risk of premature birth or other complications.
• It’s important to always take your medication exactly as your doctor prescribed.
• The adequacy of therapy is determined by periodic assessment of appropriate laboratory tests and clinical evaluation.

Therefore, oral thyroid hormone drug products are not recommended to treat this condition. Thyroid hormone products formulated for intravenous administration should be administered. If this condition is treated, a lower levothyroxine sodium dose (e.g., 1 mcg/kg/day) than that used for full replacement may be adequate to normalize the serum TSH level. Patients who are not treated should be monitored yearly for changes in clinical status and thyroid laboratory parameters.

Approximately 80% of circulating T3 is derived from peripheral T4 by monodeiodination. Reduce the SYNTHROID dosage or discontinue temporarily if signs or symptoms of overdosage occur. Initiate appropriate supportive treatment as dictated by the patient’s medical status.

More Info on this Drug

SYNTHROID should not be discontinued during pregnancy and hypothyroidism diagnosed during pregnancy should be promptly treated. The therapeutic effects of digitalis glycosides may be reduced by levothyroxine. Serum digitalis glycoside levels may be decreased when a hypothyroid patient becomes euthyroid, necessitating an increase in the dose of digitalis glycosides (see Table 2).